Senior Quality Engineer

*Position is on-site and located in Irvine, CA*

Job Summary: We are seeking a passionate and self-driven Senior Quality Engineer with deep expertise in medical device Quality Management Systems (QMS). In this hands-on role, you will be integral to developing innovative, world-class medical technologies that improve people’s lives. You will provide Quality Assurance leadership across new product development, manufacturing scale-up, Design Control, Risk Management, and CAPA resolution.

Key Duties & Responsibilities:

• Drive Quality Engineering activities throughout the New Product Development lifecycle, specifically for complex electro-mechanical devices and wearables.
• Lead risk assessment efforts (FMEA, URRA, Hazard Analysis) and develop Master Validation Plans.
• Support regulatory submissions (FDA Q-Subs, 510(k), PMA) and defend processes during audits by regulatory bodies.
• Develop, implement, and maintain QMS processes (SOPs, Work Instructions) ensuring compliance with ISO 13485, ISO 17025, and FDA QSMR.
• Reduce manufacturing defects by leading root cause investigations and implementing corrective and preventative actions (CAPA).
• Oversee product/process validations, method development, and the establishment of a Metrology program.
• Manage supplier development, conduct supplier quality audits, and ensure strict compliance across the supply chain.
• Drive a proactive "Culture of Quality" through strong cross-functional collaboration.

Minimum Qualifications:

• B.S. or higher in Biomedical, Electrical, Chemical, Mechanical, or Systems Engineering.
• 10 years of QA experience in the medical device industry (experience with complex systems strongly preferred).
• Expert-level knowledge of ISO 13485, ISO 14971, FDA QSMR, and GMP.
• Experience with cleanroom manufacturing, sterilization processes (specifically EtO), and interpreting engineering drawings (GD&T).
• Proficiency in root cause investigation tools (Fishbone, 5 Why) and statistical software (Minitab, JMP).
• Excellent problem-solving, communication, and team-building skills.
• Ability to excel in a fast-paced environment and travel up to 15%.

Desired Qualifications:

• Master’s degree in Engineering or a Technical discipline.
• Professional Quality certifications (e.g., CQE).
• Prior experience with FDA 510(k), Q-Sub, and/or PMA submissions.
• Prior experience in emerging/start-up environments and familiarity with smartphone applications.
• Work Environment & Additional Info: This role supports both R&D and Manufacturing operations, requiring regular work in a cleanroom environment and standard office settings.

Physical requirements/Work Environment

This position supports manufacturing operations, thus requires working with R&D and Manufacturing in a cleanroom environment supporting validation, process improvement and scale up for increased production and cost of goods reduction. It requires frequent sitting, standing and walking along with daily use of a computer and other digital devices. Work may entail standing for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary; therefore, the ability to operate a motor vehicle and maintain a valid Driver’s License is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Salary will be based on experience and education.